Written answers

Tuesday, 7 November 2017

Department of Health

Medicinal Products

Photo of John BrassilJohn Brassil (Kerry, Fianna Fail)
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745. To ask the Minister for Health his views on the need to amend the Health (Pricing and Supply of Medical Goods) Act 2013 to remove biosimilars from the non-interchangeable list of medicines in circumstances where the presence of biosimilars on this list unfairly undermines confidence in biosimilar medicines, notwithstanding the fact that they adhere to the same safety, quality and efficacy standards which apply to all medicines approved for use; and if he will make a statement on the matter. [46489/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The Health (Pricing and Supply of Medical Goods) Act 2013 contains provision for the establishment of a List of Interchangeable Medicinal Products whereby items can be substituted at pharmacy level. Biological medicines are not permitted to be added to this list.

The existence of this clause does not affect physician-led interchangeability of biological and biosimilar medicines. The Health Products Regulatory Authority (HPRA) guidelines on biosimilar medicines clearly support physician led switching advising that, any change should be made in consultation with the patient. Thus there is currently no need for legislative change in this area.

The National Biosimilar Medicines Policy is currently being drafted by my Department. The National Biosimilar Medicines Policy will aim to better position Ireland to benefit from current and future biosimilar medicines. The primary objective of the policy will be to increase biosimilar use in Ireland, by creating a robust framework in which biologicals and biosimilars can be safely, cost-effectively and confidently used in the health service.

Having performed research on international best practice as part of the policy development process, my Department will now begin developing an appropriate policy framework to increase the usage of biosimilar medicines in Ireland.

I expect this policy to be published in early 2018.

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